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OverweightNCT03636581

Lifestyle Intervention Program in Overweight Medical Students

A study testing Lifestyle counseling in people with Overweight, run by New York Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Overweight
What is being tested?
Lifestyle counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
8 Aug 2018to 25 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female NYITCOM students between the ages of 18-35
  • BMI ≥ 25.0
  • Body fat % >19% for males; >33% for women (will be determined by body composition scan)
  • Own their own smartphone

Who cannot join

  • People who have used weight loss smartphone applications in the past 6 month
  • People who have used an activity tracker in past 6 months
  • Anyone who answers yes to one or more questions on the PAR-Q screen
  • Any contraindication to having a duel x-ray body scan performed based on the American College of Radiology's practice guidelines

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Institute of Technology

    Old Westbury, New York, 11568

Other trials in United States

About this study

Official title: A Novel Lifestyle Intervention Program to Improve Body Composition and Chronic Disease Bio Markers in Overweight Medical Students: a Randomized Cross-over Trial

This study will be a randomized cross-over design over the course of 2 academic years. 40 subjects -20 overweight women and 20 over weight men will be recruited. Each subject will have body composition tested, blood lipid profile, and resting metabolic rate done in the beginning of the first academic year and at the end of the first academic year. The intervention group will receive activity trackers, diet counseling, and fitness counseling for one academic year. The second year, all outcome measures (a body scan, blood lipid profile, and resting metabolic rate) will be performed again at the start of the academic year 2, except the intervention group will now be the control group and the control group will now receive the same intervention. All final outcome measures will be performed at the end of the second year.

Conditions
Overweight
Being tested
Lifestyle counseling
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle counselingBehavioural

    This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.

Study groups in NCT03636581
Study groupRoleWhat they receive
InterventionExperimentalThis group will receive a smart watch to track activity and diet. This group will also receive education on nutrition and exercise.
Receives: Behavioral: Lifestyle counseling
ControlNo interventionThis group will receive a smart watch to track activity only with no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body fat percentage

    Body composition

    Measured: 4 months

Secondary outcomes (7)

  1. Step Count

    Activity based on step count

    Measured: 4 months

  2. Resting Metabolic Rate

    Resting metabolic rate changes as per oxygen consumption

    Measured: 4 months

  3. Total Cholesterol

    fasting serum mg/dL

    Measured: 4 months

  4. High Density Lipoproteins

    fasting serum mg/dL

    Measured: 4 months

  5. Low Density Lipoproteins

    fasting serum mg/dL

    Measured: 4 months

  6. Triglycerides

    fasting serum mg/dL

    Measured: 4 months

  7. Hemoglobin A1C

    fasting plasma % of total hemoglobin

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start8 Aug 2018
  3. Primary completion25 Apr 2021
  4. Study completion25 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03636581
Sponsor's protocol ID
BHS-1333
Status last verified
Jan 2022
First submitted
14 Aug 2018
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counseling in people with Overweight, run by New York Institute of Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body fat percentage (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03636581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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